Washington Post Profiles Clinical Trial in Nigeria Testing Tenofovir for HIV Prevention
The Washington Post on Wednesday profiled the Nigerian arm of an ongoing clinical trial that is testing the antiretroviral drug Viread -- which is known generically as tenofovir -- to determine if it can reduce the risk of HIV infection. Researchers in the city of Ibadan have enrolled approximately 125 commercial sex workers, who were recruited from several brothels and have been taking the drug once a day since July (Timberg, Washington Post, 12/22). NIH, CDC and the Bill & Melinda Gates Foundation are funding three separate studies of Viread, which is manufactured by Gilead Sciences. The drug is FDA-approved for use as a treatment for HIV infection and has been shown to boost immune response and lower viral levels in the bloodstreams of patients who are resistant to other antiretrovirals. CDC has granted $3.5 million to fund trial sites in San Francisco and Atlanta, while the Gates Foundation awarded a $6.5 million grant to Family Health International to conduct a randomized, placebo-controlled clinical trial including 2,000 HIV-negative volunteers at sites in Cambodia, Ghana, Cameroon, Nigeria and Malawi. NIH also awarded a $2.1 million grant to University of California-San Francisco researchers to test Viread in 960 HIV-negative Cambodian women, most of whom are commercial sex workers. However, Cambodian Prime Minister Hun Sen in August ordered a stop to the planned human clinical trial in the country because of the possible effects of the drug on trial participants (Kaiser Daily HIV/AIDS Report, 12/2). The initial results of the Nigerian study are expected in 2006, the Post reports.
Female-Controlled Prevention Method
According to researchers, one of the "most appealing aspects" of using Viread daily to reduce the risk of HIV infection is that "women could take it privately at a time of their choosing, without a husband or other sexual partner knowing," the Post reports. Married women, including those who are monogamous, currently are one of the most vulnerable groups to HIV infection because "husbands who have sexual relations with other women may be unlikely to take precautions or alert their spouses," according to the Post. "World over, it is much more difficult for somebody in a long-term, supposedly faithful relationship to use a condom," Helene Gayle -- president of the International AIDS Society and director of HIV, tuberculosis and reproductive health at the Gates Foundation -- said. If the trials find that Viread is safe and effective for HIV prevention, some say that the drug could be packaged with other medications taken on a daily basis, such as oral contraceptives, to "make it even easier to use," according to the Post. However, the trials raise a "number of scientific and ethical questions, any of which could prevent it from ever being widely administered" -- including the "safety and practicality of a long-term daily drug regimen for healthy people" and "[c]omplaints" from advocates of traditional vaccines and microbidicdes who say that the studies are "costly diversion[s] from other research," the Post reports (Washington Post, 12/22).